Eligibility Criteria for Cholecystectomy in Ambulatory Surgery

Cold laparoscopic cholecystectomy is the gold standard for the management of symptomatic vesicular stones. There is considerable controversy as to whether it should be practiced in outpatient surgery or as part of inpatient surgery, regarding to patient safety.

"Minor" surgical procedures, such as anal surgery or simple inguinal hernia interventions, were initially considered eligible for an outpatient procedure. Advances in surgical techniques, anesthesia and early rehabilitation have also made it possible to consider more "heavy" interventions, such as cholecystectomy.

The aim of this study is to identify eligible patients for laparoscopic cholecystectomy in outpatient surgery, taking surgical criteria into account.

Study Overview

• Status: Completed
• Conditions: Cholecystectomy
• Intervention / Treatment: Procedure: Cholecystectomy

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have had a laparoscopic cholecystectomy with a single cholecystectomy procedure without other associated interventions (bariatric surgery or other). Hospitalisation within the CHU Brugmann Hospital between May 2016 and November 2017.

Description

Inclusion Criteria:

• Patients who have had a laparoscopic cholecystectomy with a single cholecystectomy procedure without other associated interventions (bariatric surgery or other)

Exclusion Criteria:

• Pregnant women
• Diabetic patients under insulin treatment
• History of major abdominal surgery
• Acute cholecystitis as per anatomo-pathological examination

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cholecystectomy; Patients with a symptomatic vesicular lithiasis, having undergone cholecystectomy during a scheduled hospitalization in the CHU Brugmann Hospital between May 2016 and November 2017.	Procedure: Cholecystectomy; Cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery duration	Duration of the surgical intervention	Up to 4h
Post surgical pain	Pain killer medication administered post surgery, expressed in mg	Up to 1 day after surgery
Nausea	Occurence of nausea or vomiting post surgery	Up to 1 day after surgery
Post surgery hospitalization duration	Post surgery hospitalization duration	Up to 10 days after surgery
Medical complications after surgery	Medical complications after surgery	Up to 1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data extraction from medical files: medical history	Important surgical or medical antecedents of the patient before surgery (data extraction from medical file).	5 min
Physical status score	Physical status score (also called ASA score for American Society of Anesthesiologists score) of the patient before surgery. The ASA score ranges from I (normal healthy patient) to VI (declared brain-dead patient whose organs are being removed for donor purposes)	5 min
Body mass index	Body mass index of the patient before surgery	5 min
Hospitalisation type	Same day (ambulatory) or not	Up to 10 days after surgery
Type of surgery	Surgery performed under nuclear magnetic resonance (RMN) or RMN + endoscopic retrograde cholangiography (CWR)	Up to 4 hours

Collaborators and Investigators

• Sponsor: Pierre Wauthy
• Investigators: Principal Investigator: Levon HAKOBYAN, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2017
• Primary Completion (Actual): February 27, 2018
• Study Completion (Actual): February 27, 2018

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CHUB-cholecystectomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No